Staining agent in tablet form for making visible the formation of dental plaque and method for producing such a tinting agent

ABSTRACT

A staining agent in tablet form for making visible dental plaque contains 85 to 95% by weight lactose; 1.5 to 2.6% by weight phloxin B; 2.5 to 3.5% by weight FDA Blue No. 1; 0.15 to 0.25% by weight magnesium stearate. The staining agent is produced by direct compression tableting and can also contain 0.3 to 0.75% by weight peppermint or eucalyptus flavoring agents.

Staining agents for making visible dental plaque are known in the form of solutions, tablets, toothpaste, and gels.

U.S. Pat. No. 3,723,613 A discloses a staining agent in tablet form that contains FDC Blue No. 1 and FDC Red No. 3 in order to indicate older dental plaque in dark blue and newer dental plaque in violet-red; this provides important information in regard to the advancement of dental plaque formation and in regard to the treatment thereof.

European patent 0 421 838 B1 discloses agents for indicating dental plaque formation; the agents contain conventional water-soluble dye FDC Red No. 3. A disadvantage is that FDC Red No. 3 has an unpleasant taste; moreover, in the United States its use as a component of cosmetic products has been prohibited in the year 1989 because its innocuousness has been called into question. According to European patent 0 421 838 B1, the less bitter tasting dye FDC Red No. 40 has been proposed as a substitute dye; this dye has a stronger color intensity in comparison to other dental plaque-indicating agents, for example, FDC Blue No. 1, FDC Blue No. 2, so that these dyes are less useful as dental plaque-indicating agents than FDC Red No. 40.

In Japanese application 10175835 A, a staining agent for making visible dental plaque formation in the form of a toothpaste is described that contains phloxin as a dye.

U.S. Pat. No. 4,347,233 A discloses phloxin B in solution for caries detection.

U.S. Pat. No. 3,903,252 A discloses an agent in gel form for making visible dental plaque that contains a pharmacologically harmless organic dye component that is selected from the class of FDC Red No. 3, FDC Blue No. 1, FDC Violet No. 1 and others.

The invention has the object of providing a staining agent that is available in tablet form and is therefore especially suitable for medical surveys and medical screening, for example, in schools, that with regard to health considerations is harmless, and that is able to indicate older dental plaque as well as newer dental plaque.

As a solution to this object, a staining agent in tablet form for making visible dental plaque is proposed that contains lactose in a range of approximately 85 to 95% by weight, phloxin B in the range of approximately 1.5 to 2.6% by weight, FDA Blue No. 1 in the range of approximately 2.5 to 3.5% by weight as well as magnesium stearate in the range of 0.15 to 0.25% by weight.

By using phloxin B in addition to FDA Blue No. 1, it is achieved that older dental plaque is shown in dark blue and newer dental plaque is shown in violet-red.

Aside from the medical indication for a dentist, the staining agent according to the invention that is in tablet form can be used independent of a dental examination also by individuals as an indicator for dental plaque formation so that it practically provides also a cosmetic function.

Preferred concentrations of the individual components are disclosed in the claims 2 through 5. The employed phloxin B has the empirical formula C₂₀H₂Br₄Cl₄Na₂O₅ with the following structure:

The employed FDA Blue No. 1 has the empirical formula C₃₇H₃₄N₂Na₂O₉S₃ with the following structure:

For producing the tablets, the method of direct compression tableting is selected. In this connection, micronized dye particles of dyes phloxin B and FDA Blue No. 1 are mixed with tableting agents, wherein care must be taken that the structure of the lactose is not destroyed. The tablets after tableting are exposed to a water vapor-saturated atmosphere, preferably for a duration of 2 to 3 minutes, and the tablets take on a color mottling. This color mottling occurs otherwise in the case of white tablets during storage in a somewhat humid atmosphere; however, this causes test persons to believe that the tablets are already old and are no longer useful.

The staining agent contains also peppermint or eucalyptus flavoring agents, for example, in the range of approximately 0.3 to 0.75% by weight. 

1-7. (canceled)
 8. A staining agent in tablet form for making visible dental plaque, the staining agent comprising: 85 to 95% by weight lactose; 1.5 to 2.6% by weight phloxin B; 2.5 to 3.5% by weight FDA Blue No. 1; 0.15 to 0.25% by weight magnesium stearate.
 9. The staining agent according to claim 8, further comprising 0.3 to 0.75% by weight peppermint or eucalyptus flavoring agents.
 10. The staining agent according to claim 8, comprising: 92 to 95% by weight lactose; 2 to 2.2% by weight phloxin B; 2.7 to 3.1% by weight FDA Blue No. 1; 0.18 to 0.22% by weight magnesium stearate.
 11. The staining agent according to claim 10, comprising: 94.3% by weight lactose; 2.1% by weight phloxin B; 2.9% by weight FDA Blue No. 1; 0.2% by weight magnesium stearate.
 12. The staining agent according to claim 9, comprising peppermint or eucalyptus flavoring agents in the range of 0.5% by weight.
 13. A method for producing a staining agent according to claim 8, the method comprising the steps of: a) mixing micronized dye particles of phloxin B and FDA Blue No. 1 with lactose and magnesium stearate as tableting agents and, optionally, peppermint or eucalyptus flavoring agents to a mixture; b) tableting the mixture of step a) by direct compression tableting to tablets; c) exposing the tables of step b) to a water vapor-saturated atmosphere for approximately 2 to 3 minutes.
 14. The method according to claim 13, wherein in step a) 85 to 95% by weight lactose, 1.5 to 2.6% by weight phloxing B, 2.5 to 3.5% by weight FDC Blue No. 1, 0.15 to 0.25% by weight magnesium stearate, and optionally, 0.3 to 0.7% by weight peppermint or eucalyptus flavoring agents are mixed together. 